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Durham Connects Impact Evaluation Final Report

Pew Center on the States

Kenneth Dodge, Principal Investigator

Ben Goodman, Research Scientist

May 31, 2012

Durham Connects Final Report 2

Durham Connects Impact Evaluation Final Report

Background and Significance

Child maltreatment is an urgent national public health problem. In 2009, 762,940 U.S.

children (10 per 1,000) were identified as victims of abuse or neglect (U.S. Dept. of Health &

Human Services [U.S. DHHS], 2011). The federal response to the needs of at risk children and

families has accelerated in recent years through the Maternal, Infant, and Early Childhood Home

Visiting Program (MIECHV; http://mchb.hrsa.gov/programs/homevisiting), which provides $1.5

billion in grant funding over five years to states for expanded implementation of evidence-based

home visiting programs improving health and development outcomes for at-risk children and

families. Although the majority of the funding (75%) must be utilized to implement existing,

evidenced-based programs identified through the Home Visiting Evidence of Effectiveness study

(HomVEE; Paulsell et al., 2010), states may elect to allocate up to 25% of funds to promising

new home visiting programs that are evidence-based, but that have not yet been reviewed

through HomVEE (www.hrsa.gov/grants/manage/homevisiting/sir02082011.pdf). Thus, in

addition to supporting implementation of well-established home visiting models, MIECHV

offers an important, time-limited opportunity for expanded implementation of new, innovative

home visiting programs with promising evidence supporting impact for children and families.

Currently, the most popular maltreatment-prevention programs, including all evidence-

based programs certified as effective by HomVEE, are long-term, intensive home visiting for

high-risk, pregnant, primiparous women selected by demographic characteristics, such as

Healthy Families America (Holton & Harding, 2007) and Nurse Family Partnership (NFP; Olds

et al., 2009). The rationale for these programs is that the highest victimization rates occur among

infants under age 1 (23 per 1,000; Centers for Disease Control and Prevention, 2008) and certain

http://mchb.hrsa.gov/programs/homevisiting/

http://www.hrsa.gov/grants/manage/homevisiting/sir02082011.pdf


groups of women are at higher risk than others (Dodge et al., 1997). Although both Healthy

Families America and NFP have implemented randomized controlled trial (RCT) studies

demonstrating significant reductions in parent-reported (Healthy Families America; Harding et

al., 2007) and objective reports of child maltreatment episodes (NFP; Olds et al., 1986), impact

findings have been inconsistent across program sites (e.g., HFA reports significant reductions in

official maltreatment reports for only one of six RCT sites; Harding et al., 2007) or limited to

specific subpopulations of the treatment group (e.g., Healthy Families America; DuMont et al.,

2008; Mitchell-Herzfeld et al., 2005; NFP; Olds, Henderson, & Kitzmanm, 1994; Olds et al.,

1986). Most importantly, no targeted home visiting program has been shown to lower the

population rate of maltreatment for an entire community, despite the Institute of Medicine

mandate to move from basic science to an efficacy trial to an effectiveness trial to population

dissemination (Mrazek & Haggerty, 1994).

Failures in moving from efficacy trials to community effectiveness and population impact

have been noted for child psychotherapy (Weisz & Gray, 2008) and other psychosocial

interventions (Kazdin, 2002). Welsh et al. (2010) found that the scaling up of early family

interventions degrades impact by up to 50%, and identified four problems that must be overcome

to achieve success for a population. First, most home-visiting programs, including Healthy

Families American and NFP, rarely even try to reach the full population because of enormous

opportunity costs and targeted enrollment criteria. As noted by Guterman (1999), the debate

between universal and targeted home-visiting programs has important implications “not only for

the screening process…but also for the …subsequent configuring of services to address families’

specific needs” (p. 864). Enrolling families based on demographics, rather than a systematic

assessment of actual risk, means that not all families at high risk for maltreatment will receive


services. Further, even if a disseminated program is successful in reducing child maltreatment

among its participants by as much as one half, it would likely have only a negligible impact on

population rates of maltreatment because it targets only a small portion of the population

(Dodge, 2009). Further, Guterman’s (1999) meta-analysis of home-based child abuse prevention

programs indicated that “population-based” enrollment strategies had stronger effects on

officially-reported cases of maltreatment and on “maltreatment-related” measures of parenting

than “screening-based” enrollment strategies based on individual risk characteristics. Guterman

suggests that focusing on high-risk individuals only may inadvertently undermine overall success

and may exacerbate a mismatch between families’ needs and the services they receive. Second,

penetration and completion rates for home-visiting programs are typically low. For NFP, Olds et

al. (1994) reported that over 40% of the targeted group never enrolled in their study (and were

excluded from all analysis). Once enrolled, Harding et al. (2004) reported a 50% dropout rate

within 12 months for Healthy Families America participants, and Daro et al. (2003) reported that

only a third of families in all home-visiting programs remain for two years. Third, program

developers acknowledge that programs typically suffer degradation in fidelity, quality, and

impact when a small program is scaled up from a university context to a community population.

Olds et al. (2003) reported that families have higher attrition rates when the NFP Program is

disseminated to communities, and, even when retained, they attend fewer visits. Welsh et al.

(2010) estimate this “scale-up penalty” at 40%. Finally, programs are predicated on the

assumption that community capacity to respond to the needs of participants is sufficient. A key

component of the effectiveness of home-visiting, according to Olds et al. (1986), is the ability of

the nurse home-visitor to navigate the network of services in a community and advocate for

individualized resources, such as high-quality child care and professional mental health services.


When a program is implemented in a randomized trial with only a small proportion of families in

a community, the home visitor provides the family with a competitive advantage over non-

treated families in receiving precious resources. If a program is taken to scale, however, the

collective needs of all families may exceed community capacity to provide resources.

A Universal Approach to Home Visiting

The Durham Connects (DC) Program is an innovative, community based, universal

newborn nurse home-visiting program designed to address these existing limitations to targeted

home visiting programs. It has been developed in a community setting with complementary foci

of increasing community capacity while delivering individual services to all families. The home

visiting model is designed to be brief and inexpensive ($700 per birth) so that communities can

afford its costs. The program is delivered universally in order to achieve high penetration and

population impact, as families do not perceive participation in a universal program as

stigmatizing them as “poor or risky,” thereby maximizing community acceptance. Further,

because the program was implemented universally from the start, the program avoids decreases

in fidelity and impact reported by targeted home visiting programs after scaling-up from smaller

RCT trials. Although it is implemented universally, it focuses on triaging families according to

assessed risk and then connecting them with ongoing collaborating community resources that can

continue to support the family after program completion. Further, its goals are consistent with

those of more intensive, targeted maltreatment prevention home visiting programs, such as the

NFP (Olds et al., 2009): 1) to connect with the mother in order to enhance maternal skills and

self-efficacy; and 2) to connect the mother with matched community services such as health care,

child care, mental health care, and financial and social support based on the families unique

needs; in order to 3) promote healthy child development and family functioning.


Funding for DC piloting and implementation as a RCT study was provided by The Duke

Endowment. The Pew Center on the States provided generous funding to support an initial wave

of impact evaluation when infants were age 6-months through home interviews conducted with a

random, representative subsample of 549 Durham County families with infants born during 18-

month Durham Connects RCT period (i.e., the family of one child born on each day of the 18-

month RCT period was randomly selected to participate in the home interview; n = 269

intervention eligible families; n = 280 control group families). The following hypotheses were

examined:

1. Random assignment to Durham Connects will be associated with more connections to

community resources.

2. Random assignment to Durham Connects will be associated with higher quality family

functioning and better child health and well-being.

3. Associations between Durham Connects eligibility and improved child health and well-

being will be accounted for by greater family connections to community resources and

enhanced family functioning.

The current report provides an overview of 1) the DC program, including the home

visiting model and a description of an 18-month randomized controlled trial (RCT)

implementation of DC and subsequent impact evaluation study conducted with a random,

representative subsample of 549 families at infant age 6-months; 2) results from the 18-month

DC RCT implementation and initial impact evaluation study results; 3) conclusions and


recommendations to advance the home visiting field; and 4) limitations and future directions for

continued DC dissemination and impact evaluation.

I. The Durham Connects Universal Newborn Nurse Home Visiting Program

Theoretical Rationale: An Ecological Model of Child Maltreatment

Risk for child maltreatment accrues from factors that range from infant characteristics

that make infants harder to care for, to parental and family (microsystem) characteristics such as

depression, substance abuse, poverty, lack of social support, and intimate partner violence, to

community (exosystem and macrosystem) characteristics, such as lack of accessible resources

(Belsky, 1993; Chaffin et al., 1996). The most compelling lessons for prevention offered by this

approach are that risk for maltreatment varies across families and preventive interventions will

be most successful if they identify family-specific risk factors and target the appropriate level of

ecology. The Durham Connects program draws on this model by reaching all families, assessing

family-specific risk and protective factors across multiple levels, and connecting families with

collaborative health and human services to support their unique needs.

The ecological model further suggests that community resources must be available and

aligned to support families during the first year of life. The most effective home visiting nurse

cannot have an enduring impact if needed community resources such as health care, child care,

financial supports, and parenting supports are not available or are not accessible to families from

certain neighborhoods or income groups. The Durham Connects program has spent six years

growing a Preventive System Of Care (PSOC; Tolan & Dodge, 2005) of community services by

gaining the support of virtually all community agencies, providers, and volunteer groups in

Durham County. The PSOC is modeled after the System Of Care concept in child mental health


treatment, which focuses on the needs of the child, includes all relevant members of the child’s

ecology, and “wraps” services around the child. Durham Connects follows this model but

identifies risk rather than disorder and acts preventively. To support these efforts in

implementation, all community agency directors signed a memorandum of agreement to follow

the Preventive System of Care Model, directing increased resources toward prevention and

delivering services in a family-centric way.

The Durham Connects (DC) Home Visiting Model

DC was implemented jointly by the Durham County (NC) Health Department and Duke

University. DC consists of 4-7 intervention contacts, beginning with consenting during a

birthing-hospital visit when a staff member communicates the importance of community support

for parenting and schedules the family with an initial nurse home visit conducted when infants

are approximately 3 weeks of age during which the nurse conducts an infant and mother health

assessment and systematically assesses family unique strengths and needs, 1-2 nurse follow-up

home visits, as needed, based on nurse assessment of family needs, 1-2 nurse contacts with

community service providers to support provider connections with the family, and a staff-

member telephone or in-home follow-up one month after the nurse completes all home visits.

DC is delivered universally to mothers (and fathers when possible) through “teachings”

in important areas of health and well-being during the course of 1-3 home visits with the family

(see Table 1 for a complete list of all possible nurse teachings). After engaging the mother, the

nurse’s first task is to nurses utilize motivational interviewing techniques (Miller & Rollnick,

2002) to deliver universal intervention through “teachings” and conversation about the

importance of parenting. The intervention protocol is manualized (i.e., nurses adhere to a


standard protocol of topics to cover with each family), but delivered flexibly, so the nurse is free

to cover topics as the naturally arise in conversation, and free to spend more or less time on

specific topics based on each family’s unique strengths and needs. The nurse also provides each

family with a developmentally-informed gift bag with materials for the infant (diapers,

thermometer, books, etc.).

During the course of the home visits, the nurse also assesses and scores health and

psychosocial risk in each of 12 empirically-derived areas in 4 domains known to increase risk of

child maltreatment (Healthcare: 1. Parent Health, 2. Infant & Safety Health, and 3. Health Care

Plans; Parenting / Childcare: 4. Childcare Plans, 5. Parent-Child Relationship, 6. Management

of Infant Crying; Household Safety & Violence: 7. Household / Material Supports, 8. Family &

Community Violence, 9. History of Maltreatment; and Parent Mental Health / Well-Being: 10.

Depression / Anxiety, 11. Substance Abuse, 12. Emotional Support). Nurses also complete a

single global rating based on the overall impression of family well-being (General Impressions).

The assessment emphasizes a high inference rating system drawing on nurses’ experience and

clinical judgment about the family. The interview also incorporates structured, validated

screening instruments for psychosocial problems, including postpartum depression (Edinburgh

Postnatal Depression Scale; Cox, Holden, & Sagovsky, 1987; Wisner, Parry, & Piontek, 2002),

substance abuse (CAGE-AID; Brown, Leonard, Saunders, & Papasouliotis, 1998; Brown &

Rounds, 1995), and interpersonal / family violence (Conflict Tactics Scale – Short Form; Straus

& Douglas, 2004). At the conclusion of the interview, the nurse scores and responds to risk

separately in each area on a 4-point scale (See Table 2 for a copy of the Family Strengths and

Needs Matrix scoring system). A score of 1 (low risk) in a particular area receives no

intervention. A score of 2 (moderate risk) receives short-term nurse-delivered intervention on


that particular topic over 1-3 home visiting sessions. A score of 3 (high risk) receives a

connection (or referral) to one or more matched community resources tailored to address the

particular risk. Services in Durham include both professional (e.g., mental health practitioner,

housing authority, child care subsidies, emergency financial assistance) and para-professional

(e.g., “grandparent” mentor, volunteer) persons and agencies from both public and private

sectors. Durham Connects has created and maintains a database of several hundred appropriate

community services that is available to the nurses on laptop computers during home visits. Once

a family referral is made, the nurse and intervention support staff members also followed up to

make sure that each connection “sticks”, requiring possible additional 1-2 contacts. A score of 4

(imminent risk) receives immediate emergency intervention (e.g., contacting the police for

emergency safety concerns or an ambulance for emergency medical care). After completion of

all home visits, and with consent from the family, the nurse sends an individualized letter to the

infant's pediatrician/family practitioner and the mother’s OBGYN and regular medical provider

to inform the provider(s) about identified family needs and overall home visit outcomes.

A final telephone or in-home session is completed by a DC support staff member

approximately four weeks after the nurse has completed the case to ascertain whether the family

has received needed supports from local community resources, if additional problem-solving is

needed to address previously-identified or new family needs, and if the family was satisfied with

their DC home visit. Assessing outcomes for attempted connections with local community

agencies serves an important dual purpose for the program by 1) ensuring that community

agencies follow-through on commitments to provide services to DC-referred families; and 2)

identifying gaps in existing community services, where community needs for services currently

exceed capacity within the community. For instances where families referred to individual


agencies result in low “sticky connection” rates (i.e., the missed connection was not due to

limited capacity on the part of the agency), a DC community outreach coordinator worked

directly with that agency to troubleshoot ways to increase connection rates (e.g., developing an

in-house application form nurses or support works could complete with the family providing the

community agency with all information needed to provide services to the family). For instances

where demand exceeded community capacity (e.g., affordable, high quality child care), DC

worked with local community leaders to increase awareness of existing service gaps in the

community.

II. Durham Connects RCT Implementation and Evaluation Study Results

RCT Randomization Procedures and Evaluation Sample Selection

In order to determine whether a universal nurse home visiting program could be

implemented with high penetration and fidelity for an entire population, Durham Connects was

implemented as a randomized controlled trial (RCT) study for an 18-month period. From July 1,

2009, through December 31, 2010, all 4,782 residential births in Durham County, North

Carolina, were randomly assigned according to birthdate, with even-birth-dates assigned to

receive DC. Odd-birth-dates were assigned to receive services-as-usual (See Figure 1).

Specifically, odd-birth-date families were not contacted by DC nurses or staff members, did not

receive a DC nurse home visit, and received only those community services which they actively

sought for themselves. Post-hoc analyses matching hospital discharge records with DC

recruitment records and DC nurse home visit records confirmed that no odd-birth-date families

participated in the DC program. Program implementation was evaluated for all 2,330 even-birth-

date families. Electronic discharge records provided to DC by both hospitals in Durham County


ensured that the entire population of births for the 18-month period was identified and

randomized.

We selected a random, representative subsample of the 4,782 families to evaluate DC

program impact on multiple outcomes related to DC program implementation through intensive

in-home interviews conducted when infants were 6-months of age. A random subsample of the

broader population is a common procedure for intensive evaluation of population-level

interventions (e.g., Moving to Opportunity neighborhood re-assignment intervention; Ludwig et

al., 2011) and was utilized due to the high costs associated with blinded in-home interviewing.

Using publically available birth records, we randomly selected one birth for each day of the DC

RCT enrollment period (spanning both even and odd birth dates from July 1, 2009, through

December 31, 2010) for participation in the evaluation study (n = 549 overall; n = 269 DC-

eligible families; n = 280 control group families). Even-birth-date families were recruited

without consideration for their DC recruitment and participation outcomes. Statistical power

analyses were conducted to ensure that the evaluation sampling design was adequately powered

to detect difference between DC-eligible (intervention) and control families. Following

guidelines established by Cohen (1988) and using Gpower software

(Faul et al., 2009), power

analyses estimating at least .80 power and a significance level of .05 indicated that a sample of

549 is sufficiently powered to detect hypothesized effects: an effect size of 0.21 for continuous

variables and a 9% difference for dichotomous variables.

Recruitment for the evaluation study was conducted by an independent research team of

interviewers who had no knowledge of DC implementation. Short-form public birth records were

used to identify all eligible families. Geographic codes (geocodes) were assigned based on birth

record address to verify county of birth. Families that did not have a Durham County geocode


and families that did not give birth in Durham were removed from the selection pool. A unique

ID number was assigned to all remaining births, and one family per birth date was then randomly

selected to be solicited to participate in an IRB-approved research study examining the ways in

which family characteristics and family services utilization predict child health and development,

parent well-being, and parent-child relationship quality. Families were not informed that they

would be participating in an evaluation of the Durham Connects program in order to reduce

potential participation and response biases. When a selected child could not be located, the

family declined to participate, or the family was discovered to be ineligible (e.g., infant was

deceased or family moved out of county after birth), a replacement family with an identical

infant birth date and race/ethnicity as the original family was selected. A total of 685 families

were selected, with 549 (80.0%) participating.

We compared the 685 selected families with the population on 13 variables available

from the hospital discharge records (See Table 3). The 685 families significantly (p < .05)

differed from the population on only one variable, infant gender (selected families were more

likely to have male infants). Next, we compared the 549 participating families to the population

on the same 13 variables and found only one significant difference (interviewed families were

more likely to be Medicaid-insured or uninsured). Interview participation rates did not differ

between intervention (81%) and control (79%) families. We tested whether intervention (n =

269) and control (n = 280) groups differed on the 13 variables noted above plus 4 variables made

available by the interview and found only one significant difference (control condition had more

birth complications). We concluded that we had had obtained an evaluation sample that was

representative of the broader population, and that participation that was not biased between

intervention and control groups.


Home interviews at age 6-months were approximately 1-2 hours in length; mothers

provided information on demographic characteristics, family utilization of community resources,

family functioning across all domains of risk assessed by the Durham Connects nurse home

visitor (infant and parent health, parenting and child care, financial stability and home safety, and

parent well-being and support), and information on child development and well-being.

Additionally, research assistants completed observational ratings of the parent-child relationship

home environment quality.

Age 6-Month Evaluation Study: Dependent Variables of Interest

Dependent variables were based on interviews with the participating representative

subsample of 549 mothers when infants were age 6 months. Interviews took place in mothers’

homes at pre-arranged times; all mothers provided written consent prior to participation and

received $50 as compensation for their time.

Community connections. Mothers reported the total number of professional,

paraprofessional, and informal community resources they had utilized in the past three months

(number of community connections). This is the primary measure of the program’s proximal goal

to improve community connections. Services most frequently utilized by families included

Medicaid / SCHIP (state health insurance for children), WIC, food stamps, breastfeeding

support, child care services, and the Department of Social Services (DSS; job search assistance,

housing assistance, cash assistance, etc.).

Parenting/child care domain. Mothers completed standard reliable and valid

questionnaires assessing their parenting behaviors and knowledge. Mothers reported on use of

positive parenting behaviors (7 items, e.g., “comforted infant”; Durham Family Initiative, 2008)


and negative parenting behaviors (10 items, e.g., “shouted at infant”; Louds et al., 2004; Straus

et al., 1995) in the past three months, knowledge of infant development (10 items, e.g., “6-month-

olds know what ‘No’ means”; MacPhee, 1981), and parenting sense of competence (17 items,

e.g., “being a parent makes me tense and anxious”; Ohan, Leung, & Johnston, 2000). If the

biological father was involved with the infant, mothers reported on father-infant relationship

quality (10 items, e.g., “hugs or shows physical affection toward child”; Center for Research on

Child Wellbeing, 2008).

Trained in-home interviewers, blinded to intervention status, completed the 18-item

Responsivity and Acceptance subscales of the Infant-Toddler Home Observation for

Measurement of the Environment (IT-HOME; Caldwell & Bradley, 1984), providing an

independent rating of mother parenting quality.

Mothers completed a brief questionnaire (Bates et al., 1994) on non-parental child care

use (no vs. yes) and, if the infant had been placed in regulated childcare, the child care center

star rating (based on North Carolina’s 5-Star rating).

Family/home safety domain. Blinded interviewers completed a 5-item rating of overall

home environment quality (e.g., “the home is safe, clean, and free from hazards”; Daro &

Dworsky, 2005). Mothers currently in a relationship completed the 20-item Conflict-Tactics

Scale (Straus & Douglas, 2004), leading to a marital relationship conflict score.

Parent well-being domain. Mothers completed the 10-item Edinburgh Postnatal

Depression Scale (EDPS; Cox et al., 1987; Wisner et al., 2002), indicating possible clinical

depression (cut-point=10); the 7-item brief Generalized Anxiety Disorder-7 questionnaire (e.g.,

GAD-7; Spitzer et al., 2006) indicating possible clinical anxiety (cut-point=5); and the 8-item


CAGE and CAGE-AID questionnaires (Brown & Rounds, 1995; Brown et al., 1998) assessing

possible substance use problems (cut-point =1) in the past three months.

Health care domain. Mothers reported the most recent well-baby primary care visit.

Responses were coded as: 0) more than 1 month ago, or 1) within the last month. Mothers

reported their infant’s number of emergency medical visits in the past three months, which

summed the numbers of emergency visits to a doctor or emergency room. Mothers also reported

the infant’s number of overnights in the hospital for non-birth-related medical care in the past

three months. Finally, the total number of emergency medical care episodes was calculated by

summing these two variables.

Age 6-Month Evaluation Study: Plan of Analysis

All analyses for the impact evaluation study were conducted using SAS v.9.2 software

with a two-tailed “intent-to-treat” design that included all randomly-assigned interviewed

families without regard to intervention adherence (n = 269 intervention eligible families; n = 280

control group families). Probability levels of < .05 were called significant, and levels of < .10

were called marginally significant. Ordinary Least Squares (OLS) regression models and

multinomial logistic regression models estimated the impact of random assignment to DC on

continuous and categorical outcomes, respectively. Poisson regression models were employed

for count variables with skewed distributions (Coxe, West, & Aiken, 2009). Models included

family Medicaid status (no vs. yes), mother race/ethnicity (non-minority vs. minority), and single

parent household status (no vs. yes) as covariates.

Durham Connects RCT Implementation Results


Penetration. All eligible mothers that were successfully contacted and recruited by a DC

staff member at birth received the initial intervention message indicating the importance of

community support for parenting (n = 2,997; 99%). Further intervention services were provided

to only those families that agreed to a nurse home visit. Of the 2,330 eligible even-date birth

families, 1,863 (80.0%) consented to a nurse home visit, and 1,598 (85.8%) successfully

completed a nurse home visit (net participation = 69%). Of 1,598 participating families 40% (n =

638) were European-American, 37% (n = 591) were African-American, and 23% (n = 367) were

other/multiracial, with 26% (n = 415) reporting Hispanic ethnicity. Sixty-two percent (n = 990)

received Medicaid or had no health insurance. Forty-four percent (n = 709) were married.

Examination of differences between families that completed the program versus those that did

not suggest that families characterized as being more “at risk” were more likely to complete the

program. Specifically, mothers who completed the program were younger (Mcompleted = 28.2

years; Mnot completed = 29.1 years, p = .0001), more likely to live in lower SES neighborhoods

(Mcompleted = 53.9; Mnot completed = 58.2, p < .0001), and more likely to have had an infant that was

low birth weight (less than 2500 grams; Mcompleted = 58%; Mnot completed = 42%, p < .0001) or born

prematurely (prior to 37 weeks of age; Mcompleted = 57%; Mnot completed = 43%, p < .0001).

Fidelity. Intervention program adherence as specified in the DC nurse home visiting

manual was assessed by having an independent expert accompany the nurse or listen to an

audiotape of a home visit for 116 of 1,548 families (8%). From a list of necessary program

elements, the expert checked adherence (or not) to each model element. Additionally, the

independent expert and the nurse independently rated the family on the 12 dimensions of child

maltreatment risk assessed by the nurse during the home visit. Overall observer-rated nurse

adherence to the manualized protocol was 84% (5,476/6,550), which is judged to be high. Inter-


rater agreement on scoring of risk yielded a mean Kappa coefficient across all nurses of .69, and

across the 12 risk factors of .68 (Coefficients greater than .60 are considered substantial; Landis

& Koch, 1977).

Risk assessment, intervention, and family consumer satisfaction. 50 of 1,598 families

(3.1%) stopped assessment due to nurse-assessed emergency (scored as “4” on the 4-point scale)

or family choice. Of 1,548 assessed families, 696 (45%) were scored with at least one “3”,

indicating serious risk served best by referral to a community agency provider, 757 (49%)

received at least one “2” (but not “3” or “4”), indicating mild-to-moderate risk that was

addressed by brief nurse intervention in-home, and 93 (6%) of families received lowest-need

scores (“1”) in all 12 domains.

Nurses implemented a mean of 13.8 “teachings” to each family. Of families receiving

these interventions, most the most common were about: 1) maternal health (55.4%); 2)

household supports (46.2%); 3) infant health (39.9%); and 4) maternal well-being (36.5%).

Nurses recommended community connections for 28% of families in the health care domain,

20% in the family violence/safety domain, 11% in the parenting/child care domain, and 15% in

the parent mental health/social support domain (summing to more than 46%, allowing for

multiple referrals per family). During follow-up contacts one month after case completion,

families reported that a successful connection had been established with the community service

provider for 60% (1,009/1,671) of referrals, and community services had already been received

for 39% (651/1,671) of the total. Families reported the following aspects to be helpful (versus

not helpful): materials provided by the nurse (diapers, thermometer, books, etc.; 99%; 820/832);

discussion with the nurse about mother’s needs (98%; 812/830); and nurse “teachings” (95%;


792/830). Almost every mother indicated that she would recommend the visit to another new

mother (99%; 818/828).

Durham Connects Evaluation Study Impact Results

Descriptive statistics for all outcome variables of interest, as well as results for all

evaluation study impact analyses can be found in Table 4. Prior to conducting impact analyses,

we tested the representativeness of the DC-eligible evaluation subsample (n = 269) for DC

participation rates. The overall net participation rate for this group (76%) did not differ

significantly from the participation rate of the entire sample of interview-condition families

(69%; n = 2,330).

Community connections. Families assigned to DC (herin called DC families) accessed

14% (Mcontrol = 4.35; Mintervention = 4.96) more total community resources over the past three

months than control families (p < .0001; effect size = 0.38, calculated as (Mintervention – Mcontrol) /

average within-group standard deviation).

Parenting / childcare. DC mothers reported more total positive parenting behaviors than

control mothers (Mcontrol = 4.01; Mintervention = 4.12; p = .0047; effect size = .30); no differences,

however, were found for mother reports of negative parenting behaviors (Mcontrol = 0.34;

Mintervention = 0.32; p = .59), knowledge of infant development (Mcontrol = 0.76; Mintervention = 0.75; p

= .17), or sense of parenting competence (Mcontrol = 4.36; Mintervention = 4.36; p = .96). Blinded in-

home observers rated the parenting quality of DC mothers as higher than that of control mothers

(Mcontrol = 14.72; Mintervention = 15.15; p = .0317; effect size = .23). DC mothers also reported

marginally higher father-infant relationship quality (Mcontrol = 1.93; Mintervention = 2.08; p = .0741).


No group difference was found for the likelihood of placing an infant in out-of-home

childcare (Mcontrol = 0.53; Mintervention = 0.46; p = .14) but, contingent on receipt of out-of-home

childcare, the quality of that care as rated by the North Carolina 5-Star rating system was higher

for DC families than control families (Mcontrol = 3.98; Mintervention = 4.59; p = .0004; effect size =

.40).

Family safety / violence. Blinded in-home observers rated the home-environment quality

as significantly higher for DC families than control families (Mcontrol = 4.47; Mintervention = 4.81; p

= .0146; effect size = .27). No difference was reported for the partner relationship conflict score

(Mcontrol = -4.65; Mintervention = -4.63; p = .86).

Maternal mental health / well-being. DC mothers were not less likely than control

mothers to report possible depression (Mcontrol = 0.12; Mintervention = 0.08; p = .13) or possible

substance use problems (Mcontrol = 0.04; Mintervention = 0.06; p = .87). They were, however, 27.5%

less likely to report possible clinical anxiety (Mcontrol = 0.29; Mintervention = 0.22; p = .0469).

Infant health care. Families did not differ in the time since the last well-baby pediatric

visit (Mcontrol = 0.68; Mintervention = 0.70; p = .58). Relative to control families, families randomly

assigned to DC reported 34% (Mcontrol = 1.37; Mintervention = 0.90) fewer overall emergency

medical care episodes (p < .0001; effect size = .23); 17% (Mcontrol = 1.00; Mintervention = 0.83)

fewer emergency medical outpatient visits (p < .0539); and 82% (Mcontrol = 0.38; Mintervention =

0.07) fewer overnights in the hospital (p < .0001; effect size = .17).

Benefit-cost analysis. The per-family cost of the intervention was estimated from budget

allocations that included salaries and benefits of intervention staff members and supervisors,

local travel reimbursements, and office and supply costs. It does not include in-kind and re-

allocated time from community agencies. Intervention cost was estimated at $700 per birth. We


estimate costs of emergency medical care using published rates that indicate a local average of

$423 per emergency outpatient visit and $3,722 per hospital night (Paul et al., 2004). Using the

group means reported in Table 4 and the dollar costs above, we can apply a standard formula for

the ratio of costs of an intervention to the benefits that accrue (Drummond et al., 2001), as

follows:

BCR DC = OCOBD - OCEBD

ICEBD - ICOBD

Where BCR DC is the Benefit-Cost Ratio that accrues from random assignment to the DC

Program, OCOBD is the Output Cost for each odd-birthdate infant measured as the average per-

infant cost for emergency medical care at age 6 months, OCEBD is the Output Cost for each even-

birthdate infant measured as the average per-infant cost for emergency medical care at age 6

months, ICEBD is the average per-infant cost of the DC Program ($700), and ICOBD is the average

marginal cost of programs for control infants ($0). We obtain average costs of emergency

medical care of $2,172 for control infants ($423 in outpatient and $1,749 in overnight costs) and

$1,058 for infants assigned to DC ($351 in outpatient and $707 in overnight costs), and a

Benefit-Cost Ratio of 1.59, meaning that every $1 spent on the DC program saved $1.59 by age

six months in costs for community emergency care. For a community the size of Durham, NC,

USA, with an average of 3,187 resident births per year and DC intervention cost of $700 per

birth, a community annual investment of $2,230,900 for the DC Program would yield a

community-wide emergency health care cost savings of $3,547,131.

III. Conclusions and Recommendations to Advance the Home Visiting Field

Conclusions


Based on results from an 18-month, universal RCT implementation trial and subsequent

impact evaluation of a representative subsample of families at infant age 6-months, we conclude

that the Durham Connects (DC) Program offers a feasible, affordable, and effective public health

policy for families of newborn infants, combining a top-down commitment by community

agencies to align services according to a Preventive System of Care Model with an individually

administered, brief nurse home-visiting program that aims to reach every family. Findings

reported here indicate that when this program is implemented in large numbers, it is successful in

penetrating most of the community, can be implemented with high fidelity and reliable

assessment of individual family risk, achieves high rates of family-consumer satisfaction, and is

delivered at affordable cost. This approach offers a novel solution to the paradox faced by

existing, targeted home visiting programs by offering services universally, but also tailoring

intervention to individual-family needs by triaging families into matched community services

based on individualized nurse assessments. Further, the utilization of individual assessments to

match families to only those services that are needed offers a solution the broader paradox faced

by communities in which some at-risk families receive too many community resources

(including some that are not needed), while other at-risk families receive too few (Gutterman,

1999).

Beyond implementation results, we report the first known impact findings of a

randomized controlled trial of universal infant home-visiting implemented with large numbers of

families through intensive in-home interviews conducted with a random, representative

subsample of families born during the 18-month Durham Connects RCT period. Impact findings

indicate that random assignment to the DC Program at birth has a positive impact on reducing

mother-reported infant emergency healthcare outcomes at age 6 months. It also improves a


family’s connections to community resources, parent-child relationship quality, rates of high

quality childcare utilization, home environment quality and safety, and maternal mental health.

Effect sizes are modest for an individual family but are similar to those of longer, more intensive

home-visiting programs (e.g., Armstrong, Fraser, Dadds, & Morris, 1999; Olds et al., 1986).

Further, results from benefit-cost analyses on mother-reported infant emergency healthcare

episodes at age 6 months suggest that the program could have a cost-beneficial impact on the

population. Importantly, these cost benefit savings were observed approximately three months

after program implementation, suggesting communities may obtain significant financial returns

on initial program investments, through reduced infant emergency healthcare costs, within a

relatively brief period of time.

We conclude at this early juncture that a brief, universal, postnatal, nurse home-visiting

program can be delivered to most of the population with high fidelity and can have positive

impact on infant health and well-being. We also conclude that a public policy of universal

implementation could be cost-beneficial for a community.

Recommendations to Advance the Home Visiting Field

Based on available Durham Connects RCT implementation and impact evaluation results

to date, we suggest the following recommendations to advance the field of home visiting:

1. We recommend that communities interested in utilizing home visiting services to

promote healthy child development and family functioning incorporate a universal

home visiting model into their design. Such an approach is the only means of

achieving population-level impact. Based on community preferences and available

funding, two approaches are possible: 1) implementation of a universal home visiting


program, such as Durham Connects, as a stand-alone program. Results from the

current RCT implementation suggest such an approach could improve child well-

being and family functioning in a cost-beneficial manner for communities, although

further evaluation and replication is needed; 2) implementation of a universal home

visiting program in collaboration with a home visiting program that provides long-

term, intensive services to high risk families (e.g., NFP, Health Families America).

Although more expensive for communities to implement, such an approach may

represent an optimal approach to maltreatment prevention - utilizing a universal

program to provide short-term intervention to all families, while systematically

screening for risk and connecting high-risk families to long-term, intensive home

visiting services in a manner that more accurately identifies actual family risk than

inclusion based on demographic risk factors.

2. We recommend that the existing Durham Connects intervention model be replicated

in order to examine whether similar implementation and impact results can be

obtained in other communities. The forthcoming dissemination of the Durham

Connections program to 3-6 rural counties as part of North Carolina’s new early

childhood Race-to-the-Top initiative will provide an important test of program

effectiveness in communities with fewer relative communities resources than Durham

County. Additional replication in communities with populations differing from those

of Durham County (e.g., large urban communities) is also warranted.

3. We recommend that the Durham Connects program to be included as an evidence-

based model eligible for funding through the Maternal, Infant, and Early Childhood

Home Visiting Program (MIECHV). Although additional evaluation and replication


is needed before the Durham Connects program could be certified by the Home

Visiting Evidence of Effectiveness study (HomVEE), the current implementation and

impact results suggest that DC is warranted for consideration as a promising new

home visiting programs that is evidence-based, but that has not yet been reviewed

through HomVEE. This would allow states to use up to 25% of MIECHV funding to

incorporate a universal intervention model into their home visiting services. We

believe that such efforts would provide a critical opportunity to increase population-

level impact for communities in a cost-effective manner.

IV. Limitations and Future Directions

Limitations

Several limitations to the current work should be noted. First, findings are limited by the

implementation of DC in just one community. Further, only one-half of community births were

eligible to receive the intervention during the RCT period. While randomization within county

was necessary to ensure that the DC model was evaluated using the most rigorous experimental

design possible (i.e., randomization within county across the entire population of births is the

only way to experimentally determine that DC eligibility causes changes in outcomes of

interest), such an implementation design does not allow for evaluating the extent to which

existing community resources can support family needs across the entire population of births.

Future replications in other communities, as well as continued, universal implementation of the

Durham Connects program within Durham County (as a non-experimental community program

serving all families), will inform broader generalizability of the intervention model.


Second, impact findings are limited to a representative subsample of families with infants

born during the DC RCT period, and are based on reports by mothers and observations by

blinded coders. Further, current findings are limited to the infant’s first six months of life, and

not all outcomes of interest yielded significant impact. Future studies of administrative records

will inform the generalizability of these findings, both for the representative subsample of

families, as well as for the full RCT population of births. Further, future studies will follow up

these findings by extending cost analysis farther in the infants’ lives and more broadly to other

developmental domains, to see whether even larger savings accrue across development or costs

are simply deferred by the DC Program. Additional population outcomes will be assessed,

including reports to Child Protective Services (for a summary of all future research efforts, see

Future Directions section below).

Third, the current results are limited to main effect findings for program impact on

community connections, family functioning, and infant emergency medical care episodes for all

families using an intent-to-treat analysis plan. Program impacts on infant health and

development, however, are likely to be indirect, through program impact on more proximal

processes. Future analyses will address the mediation of distal impact on healthcare services and

child development outcomes through proximal impact on community connections and parent-

child relationship quality, and parent well-being. Further, it is possible that program impacts on

families and children may differ based on demographic characteristics or variations in program

implementation (e.g., quality of protocol administration, number of intervention contacts with

families). Future analyses will also examine the moderation of findings across subgroups within

the population and across variations in program implementation.

Future Directions


Longitudinal Impact Evaluation of DC on Children and Families. Longitudinal

assessment of family outcomes and child health and well-being is critical in order to fully

understanding the extent to which Durham Connects eligibility results in sustained

improvements in family functioning and child well-being over time, as well as the mechanisms

through which these changes occur. In order to assess the long-term impacts of the DC program,

follow-up interviews are currently being conducted with each of the 549 families who

participated in the DC impact evaluation study when infants were age six months. Currently,

additional interviews are being conducted when infants are 18- and 24-months of age and are

approximately 20- (18-months) to 45- (24-months) minutes in length. Mothers report on

demographic and contact information, community service utilization, family functioning, and

child health, development, and well-being. To date, the evaluation has been successful in

tracking and completing additional interviews with a high percentage of families.

Of the 494 families contacted to date and invited to participate in the age 18-month

interview, 436 have successfully completed interviews (88.2% completion rate), with an

additional 11 families having scheduled appointments to complete the interview (90.4%

completion / scheduling rate). Further, of the 306 families contacted to date regarding

participation in the age 24-month interview, 271 have successfully completed interviews (88.5%

completion rate), with 1 additional family having scheduled an appointment to complete the

interview (88.8% completion / scheduling rate). Importantly, fewer than 2% of families

contacted to date have declined further participation in the evaluation study. Remaining families

could not be located or declined to complete one of the interviews, but expressed an interest in

remaining in the study.


To further support long-term evaluation, a research grant from the National Institute for

Child Health and Human Development (NICHD) has been funded to continue following this

cohort of families over time. Specifically, this proposed follow-up study utilizes the existing,

innovative randomized controlled trial design to evaluate the impact of DC on population rates of

family functioning and child well-being through the transition to school (age 66 months). By

building directly from the current evaluation funded by the Pew Center on the States, ongoing

data collection efforts will allow for a more complete understanding of the magnitude of impact

over time, the specific mechanisms through which the program impacts family functioning and

child well-being, and the subgroups for whom the program is most effective. Details of the

proposed data collection timeline are provided in Table 5 below.

Administrative Record Reviews. Program effectiveness will also be assessed using

objective administrative records for emergency medical care utilization, investigations and

substantiations of child maltreatment, and family adherence to infant well-baby care schedules.

De-identified records will be collected for all children in Durham County born during the 18-

month RCT period in order to examine the population impact of the DC Program. Individually

identified records will also be collected for the 549 families participating in the age six-month

evaluation, providing the ability to examine more nuanced associations between DC Program

participation, family functioning, and child health and well-being. During the age 6-month

interview, all families provided written consent to access detailed records from birth, hospitals,

pediatric practices, and the Department of Social Services (DSS) for 5 years (through 66-

months).

Our request for identified and de-identified hospital emergency room records has been

processed by the Duke University Health Systems data center. These data were received by our


project in May 2012 and are currently being cleaned and processed for data analysis. We

anticipate having preliminary analysis results for this data by the end of Summer 2012. Further,

we have submitted a request for identified and de-identified records for investigated and

substantiated cases of child maltreatment to the North Carolina Division of Social Services (NC

DSS). We anticipate receiving NC DSS data in Summer 2012.

Durham Connects Program Dissemination and Replication. The NICHD research grant

will not provide funds for dissemination of the Durham Connects Program, evaluation of

dissemination, or policy engagement regarding community-based infant home visiting. At this

time, the DC Program is being implemented at scale (i.e., all Durham County births are now

eligible to receive DC nurse home visiting services) in the community of Durham, NC, through

temporary funds from The Duke Endowment, government, and local sources. Further, we are

preparing to implement the DC in 3-6 rural counties of North Carolina through funds from the

Early Childhood supplement to the federal Race To The Top grant. We will seek funding for

dissemination, evaluation, and policy engagement for these efforts.


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Table 1. Manualized Nurse Teachings Administered During In-Home Visits

Nurse Teaching Risk Factor

Maternal Physical Health Parental Health

Maternal Post-Delivery Recovery Parental Health

Contraception and Pregnancy Spacing Parental Health

Self-Care for Mom Parental Health

Infant Physical Growth and Development Infant Health and Safety

Infant Physical Health Infant Health and Safety

First Aid/ Emergencies/ CPR Training Classes Infant Health and Safety

Breastfeeding/ Lactation/ Pumping Infant Health and Safety

Formula Preparation / Bottle Feeding Infant Health and Safety

Sudden Infant Death Syndrome (SIDS) Infant Health and Safety

Skin Care Infant Health and Safety

Home Safety Infant Health and Safety

Infant Behavioral Development Infant Health and Safety

Hazards of Secondhand Smoke Infant Health and Safety

Diapering and Diaper Rash Treatment and Prevention Infant Health and Safety

Medicaid Health Care Plans

Mother Medical Visits / Follow-Up Health Care Plans

Childhood Immunizations and Seasonal Flu Vaccine Health Care Plans

Choosing Quality Medical Home/ Pediatrician for Baby Health Care Plans

Choosing Quality Medical Home for Mother Health Care Plans

Appropriate Use of Healthcare Services Health Care Plans

Health Insurance Coverage Health Care Plans

Infant Medical Visits / Follow-Up Health Care Plans

Quality Day Care Criteria Child Care Plans

Parenting Strategies / Knowledge Parent-Child Relationship

GED / Education Household and Material Supports

Financial Assistance Household and Material Supports

Transportation: Van Access / Bus Household and Material Supports

WIC / Food Stamps / Food Services Household and Material Supports

Domestic Violence (Partner or Child Maltreatment) Family and Community Violence

Neighborhood and Environmental Safety Family and Community Violence

Maternal Mental Health Depression / Anxiety

Substance Abuse: Alcohol Substance Abuse

Substance Abuse: Illicit drugs Substance Abuse

Substance Abuse: Smoking Substance Abuse

Marital / Partner Relations Parent Emotional Support

Social Supports Parent Emotional Support

Required In-Home Protocol Topics General Impressions


Table 2. Durham Connects Family Strengths and Needs Matrix

GENERAL

IMPRESSIONS. 1- Family doing well.

2- Family doing well.

Mild concerns addressed in

home.

3- There are some concerns in

some areas (scored or not).

Follow up.

4. Major concerns.

Follow up.

Healthcare Parenting / Child Care

Parental health Infant Health Health care plans Child Care Plans Parent-Child Relationship Management of Infant Crying

GOAL Mother is recovering from

delivery, parents in good health,

able to care for infant. Thought

given to family planning.

Infant born at or near term and is

in good health as are other

children. Family has safety

measures (e.g. CPR, smoke

alarms.)

Primary health care for infant and

mother is planned and scheduled

as needed, and health insurance is

in place.

Parent(s) has child care plan,

including emergencies and

respite with day care if

needed.

Parent(s) and infant are growing

into a sensitive and responsive

relationship.

Parent(s) describes infant crying as

normal and has planned response.

Parent can identify crying that is out of

normal range and has a plan to deal

with this.

No concerns, no

immediate needs.

1- Mother is recovering as

expected with few concerns.

1- Infant health good, as expected,

other children have health needs

addressed.

1- PCP identified for both infant

and mother, infant’s first visit

completed, next visit scheduled.

1- Parent identifies care for

each day, emergencies, and

planned respite.

1-Parent understands infant’s

needs and is responsive to infant

signals.

1- Parent sees infant crying as normal

and responds. May find cry difficult

but can cope.

Some needs for family

well being in this factor,

addressed during 1st

home visit.

2- Mother has minor health issues,

but not expected to affect

parenting. Advice and/ or

resources given during visit

2- Minor infant health concerns

(e.g., pre-term, postnatal

condition). Advice and/or

resources given during visit.

2- Uncertainty about medical

home, regular care, or insurance.

Advice and/or resources shared

and medical home established

during visit.

2- Care plan for 3 areas not in

place, but adequate plan

developed and/or resources

suggested.

2- Parent not always

understanding of infant cues and

is perplexed or frustrated.

Provided support and resources.

2- Parent is concerned about crying

and needs reassurance; developed

coping plan during visit.

Significant family

concerns and needs in

this factor. Resources

and follow up needed.

3- Mother’s health presents a

concern for infant and family.

Follow up with visit and referral,

if needed.

3- Infant or other child has health

concerns. Requires follow up visit

with link to PCP and CSC, if

applicable.

3- Uncertainty about medical

home, need, or plan. Follow up to

ensure link is made.

3- Care plan for all three

areas needed but not in place,

even following discussion.

3- Parent not aware of need or

unable to be responsive to infant

signals. Follow up with visit

and/or referral.

3- Parent is unable to cope with crying

without external intervention. Follow

up with visit and/or referral.

This is an emergency

situation for family risk

and needs.

4- Mother’s health presents

immediate risk for infant.

4- Infant or other child has health

or developmental problems

requiring immediate intervention.

4- Failure to provide for primary

care. Need immediate

intervention.

4- Emergency child care

problem. Call DSS.

4- Parent at risk of neglecting or

harming the child. Call CPS.

4- Crying is out of control for parent

and is at risk of neglecting or harming

child. Call CPS and/or other

emergency intervention.

Household Violence & Safety Parent Well-Being / Mental Health

Household/material supports Family and community violence History with parenting

difficulties

Parent well being Substance Abuse Parent emotional support

GOAL Family has financial resources

sufficient for basic needs.

Family experiences safety and

security at home and in

neighborhood.

No apparent risk factors for

maltreatment with other children

or in own childhood.

Parent(s) mental health

adequate for meeting

parenting demands.

Parent and family show no drug

using seeking in household; no

concerns about alcohol use that

could interfere with parenting.

Parent has emotional, practical, and

social support for parenting.

No concerns, no

immediate needs.

1. Financial resources adequate

for food, shelter, and transport.

Medicaid, MCC, or public

supports being utilized if

appropriate.

1. No concerns about potential

violence. Parent and infant feel

safe.

1. No known prior history of

maltreatment as a child or

parenting difficulties with own

children.

1. Parent mental health is

sound. No anxiety or

depression in excess of normal

adjustment.

1. Parent denies use now or in

past and interviewer has no

reason for concern.

1. Parent names other person(s) who

provide emotional, practical, and social

support for parenting.

Some needs for family

well being in this factor,

addressed during 1st

home visit.

2. Financial resources limited or

under-utilized. Advice and/or

resources suggested during visit.

2. Mild concerns. Issues discussed

and resource information about

emergency services left during the

visit.

2. Parent has history of

maltreatment as a child and/or

CPS involvement as adult, but

reports good resolution and plans.

Resources suggested.

2. Some concern is present

and resolved during visit.

Resources suggested as

needed.

2. Possible past history but

current use is denied.

Discussion with suggested

resources if need occurs.

2. Parent initially lacking in support,

but develops plan for seeking support

during visit.

Significant family

concerns and needs in

this factor. Resources

and follow up needed.

3. Financial resources inadequate

and/or not utilized. Follow up

and/or refer for support.

3. Concerns about safety in the

home or neighborhood. Follow up

and/or refer.

3. Recent CPS involvement and/or

ongoing concerns. Follow up

and/or refer.

3. Parent screens positive for

significant anxiety or

depression. Follow up and/or

refer.

3. Substance use is a concern.

Follow up and/or facilitate

referral to treatment.

3. Parent lacking in support, which

presents risk for family well being.

Follow up and/or refer.

This is an emergency

situation for family risk

and needs.

4. Family’s financial status is

urgent. Immediately contact DSS

field worker.

4. Serious immediate concerns

about safety. Call police or CPS.

4. Ongoing CPS investigation is

active. Contact CPS about family

needs.

4. Urgent need for mental

health intervention for parent.

Contact CPS.

4. Substance abuse a major

issue. Contact CPS or

immediate access to care.

4. Parent very isolated. Re-visit within

48 hours.


Table 3. Pre-Intervention Sample Characteristics for Population and Selected Evaluation Subsample Groups.

RCT Population vs.

Selected & Interviewed Evaluation Subsamples

Interviewed Intervention vs.

Control Evaluation Subsamples

Variable RCT Population

(n=4,780)

Selected

Evaluation

Subsample

(n=685)

Participating

Evaluation

Subsample

(n=549)

Participating

Intervention

Subsample

(n=269)

Participating

Control

Subsample

(n=280)

% Participation of selected 80.0 81.5 78.9 (p = 0.39)

% Low birth weight 10.0 09.1 (p = 0.47) 08.9 (p = 0.42) 07.8 09.6 (p = 0.39)

% Gestation < 37 weeks 08.2 06.7 (p = 0.16) 06.2 (p = 0.10) 04.6 07.7 (p = 0.15)

% Any birth complications 07.4 05.7 (p = 0.12) 06.0 (p = 0.24) 03.9 08.0 (p = 0.04)

% Caesarian section 30.6 31.7 (p = 0.55) 31.9 (p = 0.51) 32.4 31.4 (p = 0.80)

% Multiple births 02.1 02.1 (p = 0.97) 02.6 (p = 0.45) 03.4 01.8 (p = 0.24)

% Teenage mother 05.7 05.8 (p = 0.91) 06.4 (p = 0.55) 06.5 06.2 (p = 0.89)

% Medicaid / no insurance 60.7 63.1 (p = 0.22) 65.5 (p = 0.03) 63.2 67.9 (p = 0.25)

Mother age (mean, years) 28.5 28.4 (p = 0.74) 28.3 (p = 0.43) 28.3 28.5 (p = 0.69)

Mother race / ethnicity

%White, non-Hispanic 29.8 29.0 (p = 0.69) 26.3 (p = 0.10) 27.5 23.9 (p = 0.34)

% Black 36.7 38.2 (p = 0.46) 39.6 (p = 0.18) 35.7 41.4 (p = 0.17)

% Hispanic 22.5 23.2 (p = 0.68) 24.7 (p = 0.25) 24.5 23.6 (p = 0.79)

% Other 11.0 09.6 (p = 0.26) 09.4 (p = 0.24) 12.3 11.1 (p = 0.66)

Mother education (mean) — — — 05.5 05.3 (p = 0.29)

% Mother employed / in school — — — 57.6 58.2 (p = 0.88)

% Mother single, no partner — — — 36.4 42.5 (p = 0.15)

% Non-English language — — — 26.8 28.2 (p = 0.70)

% Infant female 49.6 54.3 (p = 0.02) 53.0 (p = 0.13) 49.8 55.4 (p = 0.11)

Note. For mother education level, figure is the mean on a scale of 1 to 9, with 6 or higher indicating some college attendance.

Note. Column 2 is contrasted with column 1, with significance level in parentheses. Column 3 is contrasted with column 1, with

significance level in parentheses. Column 5 is contrasted with column 4, with significance level in parentheses.

Note. Dash denotes data not available.


Intervention

(n = 269)

Control

(n = 280) Model

Variable M SD M SD B OR 95% CI p-value

Distal Outcome: Infant Health

Number of emergency medical care

episodesa,e

0.90 1.27 1.37 3.40 -0.40 — -0.56, -0.23 0.0001

Number of emergency medical visitsa,d

0.83 1.15 1.00 1.60 -0.17 — -0.35, 0.003 0.05

Number of overnights in hospitala 0.07 0.47 0.38 2.72 -1.55 — -2.04, -1.06 0.0001

Proximal Goal: Total # of community

connectionsb

4.96 2.68 4.35 2.35 0.75 — 0.41, 1.10 0.0001

Proximal Impact: Parenting and Child Care

Mother positive parenting behaviorsb 4.12 0.43 4.01 0.44 0.10 — 0.03, 0.17 0.0047

Mother negative parenting behaviorsb 0.32 0.13 0.34 0.14 -0.01 — -0.09, 0.05 0.59

Mother knowledge of infant developmentb 0.75 0.19 0.76 0.18 -0.02 — -0.05, 0.01 0.17

Mother sense of parenting competenceb 4.63 0.51 4.63 0.53 0.002 — -0.09, 0.09 0.96

Observer-rated mother parenting qualityb (n =

434)

15.15 1.50 14.72 1.80 0.31 — 0.03, 0.58 0.0317

Father – infant relationship qualityb (n = 434) 2.08 0.74 1.93 0.86 0.11 — -0.01, 0.23 0.07

Proportion using non-parental child carec 0.46 0.50 0.53 0.50 — 0.76 0.55, 1.09 0.14

Out-of-home child care quality ratingb (n =

84)

4.59 0.55 3.98 0.92 0.64 — 0.29, 0.98 0.0004

Proximal Impact: Family Safety

Observer-rated home environmentb (n = 516) 4.81 1.49 4.47 1.53 0.24 — 0.05, 0.44 0.0146

Marital relationship conflictb,f

(n = 441) -4.65 1.63 -4.63 1.68 0.03 — -0.27, 0.32 0.86

Proximal Impact: Parent Mental Health

Mother possible clinical depression disorderc 0.08 0.27 0.12 0.33 — 0.63 0.36, 1.14 0.13

Mother possible anxiety disorderc 0.22 0.41 0.29 0.46 — 0.67 0.46, 1.00 0.0469

Mother possible substance use problemsc (n =

547)

0.04 0.30 0.06 0.34 — 0.94 0.41, 2.13 0.87

Proximal Impact: Infant Health Care

Timing of most recent well-baby health visit 0.70 0.46 0.68 0.47 — 1.11 0.77, 1.59 0.58

Table 4. Descriptive Statistics and Regression Models Testing Impact of Random Assignment to Durham Connects on Infant Health, Community

Connections, and Family Behavior and Well-Being.

Note: N = 549 unless otherwise noted. All models include Medicaid status, minority race/ethnicity status, and single parent status as covariates.

a Model estimated using Poisson regression. b Model estimated using ordinary least squares regression. c Model estimated using logistic regression. d Number of emergency medical visits =

(number of emergency pediatric visits + number of emergency ER visits). e Overall use of emergency medical care = (number of emergency medical visits + number of days in hospital).

f Marital relationship = (total relationship conflict – total relationship negotiation).


Table 5. NICHD Grant Timeline with Proposed Data Collection Schedule

Timeline Infant Age Project Activity Status

Funding

Source

7/1/09 – 12/31/10 Birth Enroll; Intervene Completed Existing

Funding 1/1/10 – 6/30/11 6 months In-home interview Completed

1/1/11 – 6/30/12 18 months Telephone interview In progress; Complete in grant year 1

NICHD

7/1/11 – 12/31/12 24 months Telephone interview In progress; Complete in grant year 1

1/1/12 – 6/30/13 30 months In-home interview Complete in grant years 1-2

7/1/12 – 12/31/13 36 months Mailing contact Complete in grant years 1-2

1/1/13 – 6/30/14 42 months Telephone interview Complete in grant years 1-3

7/1/13 – 12/31/14 48 months In-home interview Complete in grant years 2-3

1/1/14 – 6/30/15 54 months Telephone interview Complete in grant years 2-4

7/1/14 – 12/31/15 60 months Mailing contact Complete in grant years 3-4

1/1/15 – 6/30/16 66 months School records; interview Complete in grant years 3-5


Figure 1. CONSORT 2010 Flow Diagram for Durham Connects RCT Implementation

Random selection of sample for

interview at age 6 mlnths (n = 355)

Did not participate (n = 75)

Participatd (n = 280)

Assessed for eligibility using hospital

discharge records (n = 5,338)

Excluded (n = 556)

Not meeting inclusion criteria

(Family did not reside in

Durham County; n = 556)

Allocated to intervention (n = 2,330)

Received allocated intervention (n = 1,598)

Did not receive allocated intervention (n = 730)

Declined intervention (n = 468)

Unable to contact (n =- 23)

Unable to schedule intervention visit (n = 95)

Moved out of county after agreeing to

participate in intervention (n = 11)

Nurse unable to complete intervention visit

(n = 185)

Allocated to services as usual (control)

(n = 2,452)

Allocation

Randomized (n = 4,782)

Enrollment

Random selection of sample for

interview at age 6 months (n= 330)

Did not participate (n = 61)

Participated (n = 269)

Analysis

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